Estimating Insulin Sensitivity in Pregnancies With Type 1 Diabetes (EISP)

February 26, 2026 updated by: Jacopo Pavan, University of Virginia

Estimating Insulin Sensitivity Fluctuations Across Pregnancies With Type 1 Diabetes

The investigators want to learn how the body's response to insulin changes during pregnancy in people with Type 1 Diabetes.

In this study, the investigators will look at information from people who used a Dexcom continuous glucose monitor (CGM) and a Tandem insulin pump while they were pregnant. Participants will fill out an online survey and agree to share their device data. The investigators will use this information to see how insulin sensitivity changes from three months before pregnancy to six months after the baby is born.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The aim of this retrospective observational study is to collect continuous glucose monitor (CGM) and insulin pump data from pregnant individuals with Type 1 Diabetes, from 3 months before conception to 6 months after delivery. This data will be used to estimate how insulin sensitivity (IS) changes across gestation, with the goal of better understanding glucose-insulin dynamics during pregnancy and develop algorithms for adapting insulin administration across gestational ages.

Participants will complete an online survey where they will provide their insulin pump serial number, date of delivery, gestational week at delivery, date of last menstrual cycle (if known), and other optional demographic information. The study team will use this information to retrieve participants' CGM and insulin infusion data from 3 months before conception to 6 months after delivery.

Up to 200 participants will be screened, with the goal of reaching 100 screened participants.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • UVA Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult individuals with T1D who received pregnancy care within the last 8 years in one of the participating sites: UVA Health (Charlottesville, VA), Northwestern Memorial Hospital (Chicago, IL).

Description

Inclusion Criteria:

  • Age >=18 years old
  • Pregnant within the last 8 years
  • Diagnosed with type 1 diabetes for at least one year at the time of pregnancy
  • Use of a Dexcom CGM system (Dexcom, Inc., CA) and Tandem insulin infusion pump (Tandem Diabetes Care, CA) across gestation, and willing to share data from this pregnancy with study staff.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Time in Target Range
Time Frame: Assessed every 2 weeks from 4 weeks pre-conception to 6 months post partum
Percentage of time blood glucose was 70mg/dL and 180mg/dL as per CGM
Assessed every 2 weeks from 4 weeks pre-conception to 6 months post partum

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Time Below Range
Time Frame: Assessed every 2 weeks from 4 weeks pre-conception to 6 months post partum
Percentage of time blood glucose was below 70mg/dL as per CGM
Assessed every 2 weeks from 4 weeks pre-conception to 6 months post partum
Percent Time Above Range
Time Frame: Assessed every 2 weeks from 4 weeks pre-conception to 6 months post partum
Percentage of time blood glucose was above 180 mg/dl as per CGM
Assessed every 2 weeks from 4 weeks pre-conception to 6 months post partum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Virginia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Northwestern Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20254424
  • 2-APF-2025-1678-A-N (Other Grant/Funding Number: BreakthroughT1D)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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